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Catalog Number QD11 |
Device Problems
Overheating of Device (1437); Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed and it was noted that the device was tested and oiled and the reported condition that the device becomes too hot was not found.However, some surface scratches are removed on the outside.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by the (b)(6) that during service and evaluation, it was observed that the attachment device had a cosmetic defect with scratches on the outside.It was noted in the service order that the device "would get too hot".His event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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